Skip to main content
OpenTrials
Completed

NCT Number: NCT05144477

Family-Authored ICU Diaries to Reduce Fear in Patients Experiencing a Cardiac Arrest (FAID Fear)

The present study will:

Aim 1: Enroll 15 family members of CA patients to (a) pilot recruitment procedures, (b) estimate retention, and (c) assess acceptability of study procedures.

Family members will be randomized to either complete an ICU diary or to a control condition, and will complete surveys in the ICU, at patient discharge, and 30 days post-discharge.

Aim 2: Obtain an estimate of the association of intervention v. control with (i) family member fear (operationalized as cardiac anxiety about the patients' cardiac condition) at hospital discharge and (ii) family member PTSS 30 days post-discharge.

Exploratory Aims: Obtain an estimate of the association of intervention v. control with family member aversive cognitions towards exercise at hospital discharge.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cardiac Arrest Behavior Cardiovascular Diseases Combat Disorders Heart Arrest Heart Diseases Mental Disorders Motor Activity Post Traumatic Stress Syndrome Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CUIMC

New York, 10032, United States

About this study

A cardiac arrest (CA) is a terrifying experience for patients, but maybe even more so for their loved ones. CA patients often have little to no memory of the CA and are often unconscious for substantial parts of their hospitalization, particularly their time in the intensive care unit (ICU) . In contrast, family members often witness all of these things, resulting in high levels of fear and psychological distress in family members. This phenomenon is so prevalent that it has been termed Post-Intensive Care Syndrome - Family (PICS - Family).

Critically, emotions are socially transmitted and memories are socially constructed. In this manner, family members can transmit their distress onto patients. Prior research has suggested that patients experiencing CA will develop memories of the CA event over time - potentially because they are trying to "fill in the gaps" in their memory. As such, family members may play a critical role in creating and cementing fear-based memories and distress in patients experiencing a CA. CA patients often report cardiac fear and preoccupation. This is not without consequence: fear-based distress, particularly early anxiety related to symptoms (e.g., rapid heartbeat) and markers for PTSS in other patient populations predicts reduced engagement in behavior necessary for secondary prevention (e.g., reduced physical activity) and increased morbidity and mortality. Distress in family members can also have an adverse impact on patients by undermining the capacity of family members to provide effective social support that can buffer patient distress.

A prior clinical trial found that family-authored diaries significantly reduced PTSS in family members (26.3% lower in intervention v. control conditions, 95% CI 4.8, 52.2) and trended towards a reduction in PTSS for patients (11.2% lower, 95% CI 15.7, 46.8). However, mechanisms of these effects were not examined, and no dyadic effects were tested. Furthermore, these previous diary studies have been conducted with the intention of sharing diaries with patients.

The present study will test the feasibility involving a similar Family-Authored ICU-diary intervention to reduce a proximal, dyadic mechanism: fear of CA in patients' family members. The target audience of the diary is thus family members, and patients will not see the diary unless the family member individually chooses to share it. The feasibility of targeting family member well-being alone is untested. The long-term goal is conducting a large scale randomized clinical trial (RCT) that tests whether a family-authored ICU diary can reduce fear of cardiac arrest in family members, and in turn, improve patients' mental wellbeing, health behaviors, and, ultimately, health outcomes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The family member of a patient who has experienced a cardiac arrest
  • Age 18 years and over
  • Able to speak, read, and write in English or Spanish
  • Participating in the CANOE study (AAAR8497) and indicated they were willing to hear about future research opportunities
  • Willing to write in a journal about their experiences

Exclusion criteria

  • Unavailable for follow-up
  • Medical or psychiatric impairment that would prevent them from complying with the research protocol

Treatment and study plan

FAID Fear Intervention

Behavioral

Participants will receive a hard-cover diary, written instructions on diary completion, and a pen. A trained research assistant will meet with the participant face to face or via telephone and explain how to use the diary. Instructions will include recommended frequency for writing (at least twice a week) and tips on how to express themselves. Potential topics will also be addressed, including what to write about in the beginning, during the ICU, and after ICU discharge. The hard copy of the diary will remain with the family member participant, and they will be asked to continue writing in the diary at least until patient discharge from the hospital. Research assistants will check in with participants via weekly telephone calls to provide prompts to remind them to use the diary and support, as needed, if the participant reports difficulty in writing diary entries. These calls will last approximately 1-5 minutes and will continue until patient discharge from the hospital.

Other names: Family-Authored ICU Diaries to Reduce Fear

Primary outcomes

  1. Proportion of Eligible Family Members of Cardiac Arrest (CA) Patients Who Agree/Consent to Participate in the Pilot Study

    Time frame: Baseline (ICU admittance)

    This is to assess feasibility of recruitment. Potential family member participants whom the study team approaches and agree/consent to take part in the study will be tallied.

    Specifically, we divided the number of family member participants who enrolled in the study by the number of potential participants referred to the study (enrolled/referred).

  2. Proportion of Enrolled Family Members Who Complete the Pilot Study

    Time frame: 30 days post-discharge

    This is to estimate/assess retention. Family members who remain in the study at the final assessment will be tallied.

    Specifically, we divided the number of family member participants who completed the study by the number of potential participants who did not complete the study (completed/did not complete).

Secondary outcomes

  1. Proportion of Family Members That Adhere to the Diary Intervention

    Time frame: Up to hospital discharge (approximately 21 days)

    This is to assess acceptability of study procedures. Family members who report completing at least 2 diary entries/week will be tallied.

    Specifically, we divided the number of family member participants in the diary intervention who adhered to the intervention by the number of participants who did not adhere to the intervention (adhered/did not adhere).

  2. Proportion of Family Members That Complete the Majority of Survey Assessments

    Time frame: Up to 30 days post-discharge

    This is to assess acceptability of study procedures. Family members who complete at least 90% of survey assessments will be tallied.

    Specifically, we divided the number of family member participants who completed at least 90% of survey assessments by the number of family member participants who completed less than 90% of survey assessments (completed/did not complete).

  3. Proportion of Family Members That Agree That the Intervention Was Acceptable

    Time frame: 30 days post-discharge

    As a measure of intervention acceptability, study will assess the proportion of participants who agree that the intervention was acceptable for reducing cardiac anxiety about the patient's heart using mean of the 4-item Acceptability of Intervention Measure (score >= 4; 1 = completely disagree, 5 = completely agree). Possible mean scores range from 1 to 5.

    Specifically, we divided the number of family member participants in the diary intervention who agreed the intervention was acceptable by the number of family member participants in the diary intervention who did not agree that the intervention was acceptable (acceptable/not acceptable).

  4. Proportion of Family Members That Agree That the Intervention Was Feasible

    Time frame: 30 days post-discharge

    As a measure of intervention acceptability, study will assess the proportion of participants who agree that the study was feasible using the mean of the 4-item Feasibility of Intervention Measure (score >= 4; 1 = completely disagree, 5 = completely agree). Possible mean scores range from 1 to 5.

    Specifically, we divided the number of family member participants in the diary intervention who agreed the intervention was feasible by the number of family member participants in the diary intervention who did not agree that the intervention was feasible (feasible/not feasible).

  5. Proportion of Family Members That Agree That the Intervention Was Appropriate

    Time frame: 30 days post-discharge

    As a measure of intervention acceptability, study will assess the proportion of participants who agree that the study was appropriate for reducing cardiac anxiety about the patient's heart using the 4-item Intervention Appropriateness Measure (score >= 4; 1 = completely disagree, 5 = completely agree). Possible mean scores range from 1 to 5.

    Specifically, we divided the number of family member participants in the diary intervention who agreed the intervention was appropriate by the number of family member participants in the diary intervention who did not agree that the intervention was appropriate (appropriate/not appropriate).

Other outcomes

  1. Cardiac Anxiety Questionnaire Fear Subscale Score

    Time frame: Hospital discharge (approximately 21 days), 30 days post-discharge

    This is to measure family members' cardiac anxiety about the patients' heart. Cardiac anxiety will be measured using the 8-item fear subscale of the Cardiac Anxiety Questionnaire and compared between intervention and control participants (higher scores indicate greater fear; 1 = never, 5 = always). Possible mean scores range from 1 to 5.

  2. Cardiac Anxiety Questionnaire Avoidance Subscale Score

    Time frame: Hospital discharge (approximately 21 days), 30 days post-discharge

    This is to measure family members' aversive cognitions towards patients' exercise. Aversive cognitions towards exercise will be measured using the 5-item avoidance subscale of the Cardiac Anxiety Questionnaire and compared between intervention and control participants (higher scores indicate greater aversive cognitions; 1 = never, 5 = always). Possible mean scores range from 1 to 5.

  3. Posttraumatic Stress Disorder Checklist Score

    Time frame: 30 days post-discharge

    This is to measure family members' posttraumatic stress symptoms in relation to the patients' cardiac arrest at discharge. Posttraumatic stress symptoms will be measured using the sum of the 20-item Posttraumatic Stress Disorder Checklist cued to the CA-event and related hospitalization and compared between intervention and control participants. A score >=33 is considered a positive screen for PTSD (higher scores indicate greater PTSD symptoms; 0 = not at all, 4 = extremely). Possible total scores range from 0 to 80.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Family-Authored ICU Diaries to Reduce Fear in Patients Experiencing a Cardiac Arrest (FAID Fear): A Pilot Intervention Study

Acronym: FAID Fear

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 3, 2021
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.